Aridol

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Mannitol, the active ingredient in ARIDOL (mannitol inhalation powder) , acts as a bronchoconstrictor
and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL (mannitol inhalation powder) is
for diagnostic purposes only. Bronchial challenge testing with ARIDOL (mannitol inhalation powder) should
only be conducted by trained professionals under the supervision of a physician
familiar with all aspects of the bronchial challenge test and the management
of acute bronchospasm. Medications (such as short acting inhaled beta-agonist)
and equipment to treat severe bronchospasm must be present in the testing area.
If severe bronchospasm occurs it should be treated immediately by administration
of a short acting inhaled beta-agonist. Because of the potential for severe
bronchoconstriction, the bronchial challenge testing with ARIDOL (mannitol inhalation powder) should not
be performed in any patient with clinically apparent asthma or very low baseline
pulmonary function tests (e.g., FEV1 < 1-1.5 liters or < 70%
of the predicted values) [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

D-mannitol (referred to throughout as mannitol), the active ingredient in ARIDOL (mannitol inhalation powder)
is a hexahydric alcohol, that is a sugar alcohol, with the following chemical
name (2R,3R,4R,5R)-hexane-1,2,3,4,5,6­hexol and chemical structure:

Mannitol is a white or almost white crystalline powder of free-flowing granules
with an empirical formula of C6H14O6 and molecular
weight of 182.2. Mannitol is freely soluble in water, and very slightly soluble
in alcohol. Mannitol shows polymorphism.

The ARIDOL (mannitol inhalation powder) bronchial challenge test kit contains one single patient use dry
powder inhaler and 3 consecutively numbered foil blister packs containing a
total of 19 capsules of mannitol for oral inhalation. All except the 0 mg printed
hard gelatin capsules contain dry powder mannitol for oral inhalation. The accompanying
dry powder inhaler is a plastic device used for inhaling the capsules. All doses
are to be administered using the same device supplied with each kit without
washing or sterilizing the device at anytime during the test.

To use the delivery system, a mannitol capsule is placed in the well of the
inhaler, and the capsule is pierced by pressing and releasing the buttons on
the side of the device. The mannitol dry powder is dispersed into the air stream
when the patient inhales rapidly and deeply through the mouthpiece.

There are no inactive ingredients in the mannitol capsules supplied with the
ARIDOL (mannitol inhalation powder) bronchial challenge test kit. The 0 mg capsule and the bodies of the
5, 10, 20 and 40 mg capsules are clear. The white caps (5 mg) contain titanium
dioxide. The yellow caps (10 mg) contain titanium dioxide and yellow iron oxide.
The pink caps (20 mg) and red caps (40 mg) contain titanium dioxide and red
iron dioxide. The inhaler is a plastic device used for administering mannitol
to the lungs. The amount of drug delivered to the lung will depend on patient
factors, such as inspiratory flow rate and inspiratory time. Under standardized
in vitro testing at a fixed flow rate of 60 L/min for 2 seconds, the
delivered dose from the inhaler from each of the 5, 10, 20 and 40 mg capsules
is approximately 3.4, 7.7, 16.5 and 34.1 mg, respectively. Peak inspiratory
flow rates (PIFR) achievable through the inhaler were evaluated in healthy and
asthmatic individuals ranging from 7 to 65 years of age and with % FEV1
of predicted ranging from 67% to 123%. PIFR achieved in the study was at least
70.8 L/min in all subjects assessed. The mean PIFR was 118.2 L/min and approximately
ninety percent of each population studied generated a PIFR through the device
exceeding 90 L/min.

Last reviewed on RxList: 10/29/2010
This monograph has been modified to include the generic and brand name in many instances.